This book focuses on sterilizing grade filters in the biopharmaceutical industry, emphasizing practical applications of universal and dependable operational protocols, integrity testing, and troubleshooting to streamline the production and preparation of pharmaceuticals.
Addresses the complexities of globalizing redundancy in filtration!
Enabling educated developmental, procedural, and regulatory judgments to be made in the manufacturing of sterile health care products, Sterile Filtration
considers how many filters should be in the process stream
examines the existence of nanobacteria and viable but nonculturable organisms
covers pore size designations, distributions, architecture, and numbers
discusses the latest findings in bubble point and diffuse flow measurements
describes pre- and postfiltration, up- and downstream testing, and after-stream sterilizations
details wetting liquid, polymer, temperature, and water purity effects
explains sieve retention, size exclusion, adsorptive sequestrations, charge-related phenomena, gravitational settling, and interference factors in liquids and gases
outlines filter validation, requirements, and operational specifics
Advocating separation in addition to physical destruction of microorganisms, Sterile Filtration is a reference essential for pharmaceutical scientists; biotechnologists; microbiologists; virologists; process and chemical engineers; plant, production, validation, and quality control managers in the pharmaceutical and biotechnology industries; and upper-level undergraduate and graduate school students in these disciplines.
Table of Contents
Filter Porosity: Its Genesis and Character
The Polymeric Matrix and Its Influences
Membrane Fouling, Cleaning, and Sanitization
Flow and Pressure, Flow Decay, and Filter Sizing
Mechanism of Particle Removal from Liquid
Mechanisms of Particle Removal from Air and Other Gases
Filter Integrity Testing
Cartridges, Cartridge Holders, and Their Care
Validation of Filtrative Sterilization
From the foreword…
…the authors of these chapters bring an abundance of technical knowledge and experience to this endeavor. Filters are all around us in sterile product manufacturing, and their selection, use, validation, and testing represent an essential fundamental discipline. This book will provide an analytical mind with basic scientific insight into this essential, dynamic, and still somewhat controversial area of contamination prevention.
"-James E. Akers Akers, Kennedy & Associates
Kansas City, Missour
"…well referenced and supported by appropriate tables and figures….
…a very worthwhile book….contains information useful to both experienced practitioners and students alike…will be a very worthwhile contribution to a reference section.
"-Indian Journal of Toxicology